Epidemiology and outcomes in patients with anemia of CKD not on dialysis from a large US healthcare system database: a retrospective observational study.

BACKGROUND: Optimal management of anemia of chronic kidney disease (CKD) remains controversial. This retrospective study aimed to describe the epidemiology and selected clinical outcomes of anemia in patients with CKD in the US. METHODS: Data were extracted from Henry Ford Health System databases. Adults with stages 3a-5 CKD not on dialysis (estimated glomerular filtration rate < 60 mL/min/1.73m2) between January 1, 2013 and December 31, 2017 were identified. Patients on renal replacement therapy or with active cancer or bleeding were excluded. Patients were followed for ≥12 months until December 31, 2018. Outcomes included incidence rates per 100 person-years (PY) of anemia (hemoglobin < 10 g/dL), renal and major adverse cardiovascular events, and of bleeding and hospitalization outcomes. Adjusted Cox proportional hazards models identified factors associated with outcomes after 1 and 5 years. RESULTS: Among the study cohort (N = 50,701), prevalence of anemia at baseline was 23.0%. Treatments used by these patients included erythropoiesis-stimulating agents (4.1%), iron replacement (24.2%), and red blood cell transfusions (11.0%). Anemia incidence rates per 100 PY in patients without baseline anemia were 7.4 and 9.7 after 1 and 5 years, respectively. Baseline anemia was associated with increased risk of renal and major cardiovascular events, hospitalizations (all-cause and for bleeding), and transfusion requirements. Increasing CKD stage was associated with increased risk of incident anemia, renal and major adverse cardiovascular events, and hospitalizations. CONCLUSIONS: Anemia was a prevalent condition associated with adverse renal, cardiovascular, and bleeding/hospitalization outcomes in US patients with CKD. Anemia treatment was infrequent.

Icodextrin Versus Glucose Solutions for the Once-Daily Long Dwell in Peritoneal Dialysis: An Enriched Systematic Review and Meta-analysis of Randomized Controlled Trials.

RATIONALE & OBJECTIVE: The efficacy and safety of icodextrin versus glucose-only peritoneal dialysis (PD) regimens is unclear. The aim of this study was to compare once-daily long-dwell icodextrin versus glucose among patients with kidney failure undergoing PD. STUDY DESIGN: Systematic review of randomized controlled trials (RCTs), enriched with unpublished data from investigator-initiated and industry-sponsored studies. SETTING & STUDY POPULATIONS: Individuals with kidney failure receiving regular PD treatment enrolled in clinical trials of dialysate composition. SELECTION CRITERIA FOR STUDIES: Medline, Embase, CENTRAL, Ichushi Web, 10 Chinese databases, clinical trials registries, conference proceedings, and citation lists from inception to November 2018. Further data were obtained from principal investigators and industry clinical study reports. DATA EXTRACTION: 2 independent reviewers selected studies and extracted data using a prespecified extraction instrument. ANALYTIC APPROACH: Qualitative synthesis of demographics, measurement scales, and outcomes. Quantitative synthesis with Mantel-Haenszel risk ratios (RRs), Peto odds ratios (ORs), or (standardized) mean differences (MDs). Risk of bias of included studies at the outcome level was assessed using the Cochrane risk-of-bias tool for RCTs. RESULTS: 19 RCTs that enrolled 1,693 participants were meta-analyzed. Ultrafiltration was improved with icodextrin (medium-term MD, 208.92 [95% CI, 99.69-318.14] mL/24h; high certainty of evidence), reflected also by fewer episodes of fluid overload (RR, 0.43 [95% CI, 0.24-0.78]; high certainty). Icodextrin-containing PD probably decreased mortality risk compared to glucose-only PD (Peto OR, 0.49 [95% CI, 0.24-1.00]; moderate certainty). Despite evidence of lower peritoneal glucose absorption with icodextrin-containing PD (medium-term MD, -40.84 [95% CI, -48.09 to-33.59] g/long dwell; high certainty), this did not directly translate to changes in fasting plasma glucose (-0.50 [95% CI, -1.19 to 0.18] mmol/L; low certainty) and hemoglobin A1c levels (-0.14% [95% CI, -0.34% to 0.05%]; high certainty). Safety outcomes and residual kidney function were similar in both groups; health-related quality-of-life and pain scores were inconclusive. LIMITATIONS: Trial quality was variable. The follow-up period was heterogeneous, with a paucity of assessments over the long term. Mortality results are based on just 32 events and were not corroborated using time-to-event analysis of individual patient data. CONCLUSIONS: Icodextrin for once-daily long-dwell PD has clinical benefit for some patients, including those not meeting ultrafiltration targets and at risk for fluid overload. Future research into patient-centered outcomes and cost-effectiveness associated with icodextrin is needed.

Patient-Centric User-Interface in Automated Peritoneal Dialysis: Impact on Training and Outcomes at a Single Center.

BACKGROUND: AMIA cycler is a new automated peritoneal dialysis (APD) system, which was approved by FDA in 2015, which is more patient centric due to its features of voice guidance and touch screen. We retrospectively studied if these patient-centric features translated into better patient outcomes. METHODS: We compared 18 patients on AMIA cycler to 18 patients on conventional APD system. Data regarding training duration, dialysis adequacy, laboratory data, and peritonitis incidence were obtained using chart review and compared between the 2 groups. RESULTS: The AMIA group had 33% reduction in the duration of training period compared to the conventional group. All other end points including dialysis adequacy, electrolytes, peritonitis incidence, exit site infections, and dropout rates were not found to be different between both the groups. CONCLUSION: AMIA cycler is superior to the conventional cycler in significantly reducing the training time while having similar clinical outcomes. Further studies are needed to validate this data.

Patient-reported advantages and disadvantages of peritoneal dialysis: results from the PDOPPS.

BACKGROUND: Patient-reported measures are increasingly recognized as important predictors of clinical outcomes in peritoneal dialysis (PD). We sought to understand associations between patient-reported perceptions of the advantages and disadvantages of PD and clinical outcomes. METHODS: In this cohort study, 2760 PD patients in the Peritoneal Dialysis Outcomes and Practice Patterns Study (PDOPPS) completed a questionnaire on their PD experience, between 2014 and 2017. In this questionnaire, PDOPPS patients rated 17 aspects of their PD experience on a 5-category ordinal scale, with responses scored from - 2 (major disadvantage) to + 2 (major advantage). An advantage/disadvantage score (ADS) was computed for each patient by averaging their response scores. The ADS, along with each of these 17 aspects, were used as exposures. Outcomes included mortality, transition to hemodialysis (HD), patient-reported quality of life (QOL), and depression. Cox regression was used to estimate associations between ADS and mortality, transition to HD, and a composite of the two. Logistic regression with generalized estimating equations was used to estimate cross-sectional associations of ADS with QOL and depression. RESULTS: While 7% of PD patients had an ADS < 0 (negative perception of PD), 59% had an ADS between 0 and < 1 (positive perception), and 34% had an ADS ≥1 (very positive perception). Minimal association was observed between mortality and the ADS. Compared with a very positive perception, patients with a negative perception had a higher transition rate to HD (hazard ratio [HR] = 1.67; 95% confidence interval [CI]: 1.21, 2.30). Among individual items, "space taken up by PD supplies" was commonly rated as a disadvantage and had the strongest association with transition to HD (HR = 1.28; 95% CI 1.07, 1.53). Lower ADS was strongly associated with worse QOL rating and greater depressive symptoms. CONCLUSIONS: Although patients reported a generally favorable perception of PD, patient-reported disadvantages were associated with transition to HD, lower QOL, and depression. Strategies addressing these disadvantages, in particular reducing solution storage space, may improve patient outcomes and the experience of PD.

Biocompatibility of a new PD solution for Japan, Reguneal™, measured as in vitro proliferation of fibroblasts.

BACKGROUND: The aim of this study was to investigate in vitro biocompatibility of Reguneal™, a new bicarbonate containing peritoneal dialysis fluid (PDF) for Japan, and compare it with other PDFs available in that country. METHODS: We assessed basal cytotoxicity using in vitro proliferation of cultured fibroblasts, L-929, determining the quantity of living cells by the uptake of Neutral Red. Levels of ten glucose degradation products (GDPs) were measured by a validated ultrahigh-performance liquid chromatography method in combination with an ultraviolet detector. We compared inhibition of fibroblast cell growth between brands of PDF, adjusting for dextrose and GDP concentrations using random-effects mixed models. RESULTS: The results demonstrate that cytotoxicity of Reguneal™ is comparable to a sterile-filtered control and is less cytotoxic than most of the other PDFs, most of which significantly inhibited cell growth. As a "class effect", increasing dextrose and GDP concentrations were non-significantly but positively associated with cytotoxicity. As a "brand effect", these relationships varied widely between brands, and some PDFs had significant residual effects on basal cytotoxicity through mechanisms that were unassociated with either dextrose or GDP concentration. CONCLUSION: Our study suggests that Reguneal™ is a biocompatible PDF. The results of our study also highlight that dextrose and GDPs are important for biocompatibility, but alone are not a complete surrogate. The results of our study need to be confirmed in other tissue culture models, and should lead to further research on determinants of biocompatibility and the effect of such PDFs on clinical outcomes.

Remote Monitoring of Automated Peritoneal Dialysis Patients: Assessing Clinical and Economic Value.

BACKGROUND: For chronic kidney disease patients who progress to end-stage renal disease, survival is dependent on renal replacement therapy in the form of kidney transplantation or chronic dialysis. Peritoneal dialysis (PD), which can be performed at home, is both more convenient and less costly than hemodialysis that requires three 4-h visits per week to the dialysis facility and complicated equipment. Remote therapy management (RTM), technologies that collect medical information and transmit it to healthcare providers for patient management, has the potential to improve the outcomes of patients receiving automated peritoneal dialysis (APD) at home. OBJECTIVE: Estimate through a simulation study the potential impact of RTM on APD patients use of healthcare resources and costs in the United States, Germany, and Italy. METHODS: Twelve APD patient profiles were developed to reflect potential clinical scenarios of APD therapy. Two versions of each profile were created to simulate healthcare resource use, one assuming use of RTM and one with no RTM. Eleven APD teams (one nephrologist, one nurse) estimated resources that would be used. RESULTS: Results from U.S., German, and Italian clinicians found that RTM could avoid use of 59, 49, and 16 resources over the 12 profiles, respectively. Estimated reduced utilization across the three countries ranged from one to two hospitalizations, one to four home visits, two to five emergency room visits, and four to eight unplanned clinic visits. Total savings across all scenarios were $23,364 in the United States, $11,477 in Germany, and $7,088 in Italy. CONCLUSION: In a simulated environment, early intervention enabled by RTM reduced healthcare resource utilization and associated costs.

A new peritoneal dialysis fluid for Japanese patients: a randomized non-inferiority clinical trial of safety and efficacy.

BACKGROUND: We report here two new peritoneal dialysis fluids (PDFs) for Japan [BLR 250, BLR 350 (Baxter Limited, Japan)]. The PDFs use two-chamber systems, and have bicarbonate and lactate buffer to a total of 35 mmol/L. In separate trials, the new PDFs were compared to two "standard" systems [PD-4, PD-2 (Baxter Limited, Japan)]. The trials aimed to demonstrate non-inferiority of peritoneal creatinine clearance (pCcr), peritoneal urea clearance (pCurea) and ultrafiltration volume (UF), and compare acid-base and electrolyte balance. METHODS: We performed randomized, multicenter, parallel group, controlled, open-label clinical trials in stable continuous ambulatory peritoneal dialysis (CAPD) patients. The primary endpoints were pCcr and UF. The secondary endpoints were serum bicarbonate and peritoneal urea clearance. The active phase was 8 weeks. These trials were performed as non-inferiority studies, with the lower limit of non-inferiority for pCcr and UF set at 3.2 L/week/1.73 m2 and 0.12 L/day, respectively. RESULTS: 108 patients (28 centers) and 103 patients (29 centers) took part in the two trials. Groups were well balanced at baseline. The investigative PDFs were non-inferior to the "standard" ones in terms of primary endpoints, comparable in terms of pCurea, and superior in terms acid-base balance, especially correcting those with over-alkalinization at baseline. CONCLUSIONS: We demonstrated fundamental functionality of two new PDFs and showed superior acid-base balance. Given the propensity of Japanese CAPD patients for alkalosis, it is important to avoid metabolic alkalosis which is associated with increased cardiovascular mortality risk and accelerated vascular calcification. The new PDFs are important progress of CAPD treatment for Japanese patients.

Overcoming Barriers in Kidney Health-Forging a Platform for Innovation.

Innovation in kidney diseases is not commensurate with the effect of these diseases on human health and mortality or innovation in other key therapeutic areas. A primary cause of the dearth in innovation is that kidney diseases disproportionately affect a demographic that is largely disenfranchised, lacking sufficient advocacy, public attention, and funding. A secondary and likely consequent cause is that the existing infrastructure supporting nephrology research pales in comparison with those for other internal medicine specialties, especially cardiology and oncology. Citing such inequities, however, is not enough. Changing the status quo will require a coordinated effort to identify and redress the existing deficits. Specifically, these deficits relate to the need to further develop and improve the following: understanding of the disease mechanisms and pathophysiology, patient engagement and activism, clinical trial infrastructure, and investigational clinical trial designs as well as coordinated efforts among critical stakeholders. This paper identifies potential solutions to these barriers, some of which are already underway through the Kidney Health Initiative. The Kidney Health Initiative is unique and will serve as a current and future platform from which to overcome these barriers to innovation in nephrology.

Contrasting Perceptions of Home Dialysis Therapies Among In-Center and Home Dialysis Staff.

Home dialysis offers many advantages over in-center dialysis, but peritoneal dialysis and home hemodialysis are infrequently used. To better understand why, a survey of dialysis healthcare professionals (N = 273) in the United States was conducted to assess their knowledge, perceptions, and beliefs about home dialysis modalities. Most survey respondents demonstrated a lack of knowledge about home dialysis and perceived many barriers to home therapy, which may affect patient modality choice; however, 90% of respondents stated they would choose home dialysis for themselves if they required dialysis. Additional staff education may help reduce misperceptions, address knowledge gaps, and subsequently, increase use of home modalities.

Effect of Remote and Virtual Technology on Home Dialysis.

In the United States, regulatory changes dictate telehealth activities. Telehealth was available to patients on home dialysis as early as 2019, allowing patients to opt for telehealth with home as the originating site and without geographic restriction. In 2020, coronavirus disease 2019 was an unexpected accelerant for telehealth use in the United States. Within nephrology, remote patient monitoring has most often been applied to the care of patients on home dialysis modalities. The effect that remote and virtual technologies have on home dialysis patients, telehealth and health care disparities, and health care providers' workflow changes are discussed here. Moreover, the future use of remote and virtual technologies to include artificial intelligence and artificial neural network model to optimize and personalize treatments will be highlighted. Despite these advances in technology challenges continue to exist, leaving room for future innovation to improve patient health outcome and equity. Prospective studies are needed to further understand the effect of using virtual technologies and remote monitoring on home dialysis outcomes, cost, and patient engagement.

Training patients for automated peritoneal dialysis: A survey of practices in six successful centers in the United States.

In the United States, the majority of patients on peritoneal dialysis (PD) use a cycler or automated peritoneal dialysis (APD). The aim of this study was the identification of common features in nurse-led APD training programs that were likely to contribute to successful home dialysis. This study collected data on nurse-led APD training programs in six high-performing PD centers. A 13-point survey, which focused on training tools, topics covered methods used, and level of support at home, was administered during group face-to-face interviews with the PD training nurses. Data were reviewed for trends between centers. Training programs in all six centers focused on essential information and skill sets to begin home dialysis using APD, with simple instructions and a hands-on approach. Every center initially trained patients on continuous ambulatory PD before APD. The clinics provided ongoing education, reinforcement, and retraining of concepts and skills through discussion, quizzes, and topic-specific monthly training sessions. All clinics provided 24-hour support for patients. Adopting the best practices identified in this study has the potential to improve APD training.

Contemporary outcomes of anemia in US patients with chronic kidney disease.

BACKGROUND: Long-term clinical outcome data from patients with non-dialysis-dependent (NDD) chronic kidney disease (CKD) are lacking. We characterized patients with NDD-CKD and anemia using real-world data from the USA. METHODS: This retrospective longitudinal observational study evaluated integrated Limited Claims and Electronic Health Record Data (IBM Health, Armonk, NY), including patients ≥18 years with two or more estimated glomerular filtration rate (eGFR) measures <60 mL/min/1.73 m2 ≥90 days apart. Anemia was defined as the first observed hemoglobin <10 g/dL within 6-month pre- and post-CKD index date. Data were analyzed from January 2012 to June 2018. Patients with documented iron-deficiency anemia at baseline were excluded. RESULTS: Comprising 22 720 patients (57.4% female, 63.9% CKD stage 3, median hemoglobin 12.5 g/dL), median (interquartile range) follow-up for patients with and without anemia were 2.9 (1.5-4.4) and 3.8 (2.2-4.8) years, respectively. The most prevalent comorbidities were dyslipidemia (57.6%), type 2 diabetes mellitus (38.8%) and uncontrolled hypertension (20.0%). Overall, 23.3% of patients had anemia, of whom 1.9% and <0.1% received erythropoiesis-stimulating agents (ESAs) or intravenous iron, respectively. Anemia prevalence increased with CKD stage from 18.2% (stage 3a) to 72.8% (stage 5). Patients with anemia had a higher incidence rate of hospitalizations for heart failure (1.6 versus 0.8 per 100 patient-years), CKD stage advancement (43.5 versus 27.5 per 100 patient-years), and a 40% eGFR decrease (18.1 versus 7.3 per 100 patient-years) versus those without anemia. CONCLUSIONS: Anemia, frequently observed in NDD-CKD and associated with adverse clinical outcomes, is rarely treated with ESAs and intravenous iron. These data suggest that opportunities exist for improved anemia management in patients with NDD-CKD.

Variation in Peritoneal Dialysis Time on Therapy by Country: Results from the Peritoneal Dialysis Outcomes and Practice Patterns Study.

BACKGROUND AND OBJECTIVES: Quantifying contemporary peritoneal dialysis time on therapy is important for patients and providers. We describe time on peritoneal dialysis in the context of outcomes of hemodialysis transfer, death, and kidney transplantation on the basis of the multinational, observational Peritoneal Dialysis Outcomes and Practice Patterns Study (PDOPPS) from 2014 to 2017. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: Among 218 randomly selected peritoneal dialysis facilities (7121 patients) in the PDOPPS from Australia/New Zealand, Canada, Japan, Thailand, the United Kingdom, and the United States, we calculated the cumulative incidence from peritoneal dialysis start to hemodialysis transfer, death, or kidney transplantation over 5 years and adjusted hazard ratios for patient and facility factors associated with death and hemodialysis transfer. RESULTS: Median time on peritoneal dialysis ranged from 1.7 (interquartile range, 0.8-2.9; the United Kingdom) to 3.2 (interquartile range, 1.5-6.0; Japan) years and was longer with lower kidney transplantation rates (range: 32% [the United Kingdom] to 2% [Japan and Thailand] over 3 years). Adjusted hemodialysis transfer risk was lowest in Thailand, but death risk was higher in Thailand and the United States compared with most countries. Infection was the leading cause of hemodialysis transfer, with higher hemodialysis transfer risks seen in patients having psychiatric disorder history or elevated body mass index. The proportion of patients with total weekly Kt/V ≥1.7 at a facility was not associated with death or hemodialysis transfer. CONCLUSIONS: Countries in the PDOPPS with higher rates of kidney transplantation tended to have shorter median times on peritoneal dialysis. Identification of infection as a leading cause of hemodialysis transfer and patient and facility factors associated with the risk of hemodialysis transfer can facilitate interventions to reduce these events. PODCAST: This article contains a podcast at https://www.asn-online.org/media/podcast/CJASN/2022_05_31_CJN16341221.mp3.

Low Serum Potassium Levels and Clinical Outcomes in Peritoneal Dialysis-International Results from PDOPPS.

INTRODUCTION: Hypokalemia, including normal range values <4 mEq/l, has been associated with increased peritonitis and mortality in patients with peritoneal dialysis. This study sought to describe international variation in hypokalemia, potential modifiable hypokalemia risk factors, and the covariate-adjusted relationship of hypokalemia with peritonitis and mortality. METHODS: Baseline serum potassium was determined in 7421 patients from 7 countries in the Peritoneal Dialysis Outcomes and Practice Patterns Study (2014-2017). Association of baseline patient and treatment factors with subsequent serum potassium <4 mEq/l was evaluated by logistic regression, whereas baseline serum potassium levels (4-month average and fraction of 4 months having hypokalemia) on clinical outcomes was assessed by Cox regression. RESULTS: Hypokalemia was more prevalent in Thailand and among black patients in the United States. Characteristics/treatments associated with potassium <4 mEq/l included protein-energy wasting indicators, lower urine volume, lower blood pressure, higher dialysis dose, greater diuretic use, and not being prescribed a renin-angiotensin system inhibitor. Persistent hypokalemia (all 4 months vs. 0 months over the 4-month exposure period) was associated with 80% higher subsequent peritonitis rates (at K <3.5 mEq/l) and 40% higher mortality (at K <4.0 mEq/l) after extensive case mix/potential confounding adjustments. Furthermore, adjusted peritonitis rates were higher if having mean serum K over 4 months <3.5 mEq/l versus 4.0-4.4 mEq/l (hazard ratio, 1.15 [95% confidence interval, 0.96-1.37]), largely because of Gram-positive/culture-negative infections. CONCLUSIONS: Persistent hypokalemia is associated with higher mortality and peritonitis even after extensive adjustment for patient factors. Further studies are needed to elucidate mechanisms of these poorer outcomes and modifiable risk factors for persistent hypokalemia.

Increased cardiovascular risk associated with reduced kidney function.

BACKGROUND: Individuals with chronic kidney disease (CKD) are at substantial risk for cardiovascular mortality, but the risk associated with specific glomerular filtration rates (GFRs) is unknown. The objective of this study was to investigate the relationship between level of kidney function and the risk of cardiovascular mortality in a diverse population. METHODS AND RESULTS: This was a nonconcurrent cohort study of 34,982 ambulatory patients. Kidney function was entered into the model as a time-dependent variable to minimize misclassification and allow for improved estimate of the effect of decreasing GFR on cardiovascular mortality. The adjusted hazard ratio for cardiovascular mortality was 1.00 (95% CI 0.93-1.06) with an estimated GFR (eGFR) of 45-59; 1.77 (95% CI 1.65-1.89) with an eGFR 30-44; 3.75 (95% CI 3.47-4.06) with an eGFR 15-29, and 3.83 (95% CI 3.40-4.33) with an eGFR <15. CONCLUSION: We demonstrate a graded risk of cardiovascular mortality with decreasing GFR, with a marked increase with an eGFR <45 ml/min/1.73 m(2). These data also suggest that the availability of eGFR to physicians has had little impact on reducing the cardiovascular risk facing individuals with CKD. Our findings further highlight the public health significance of CKD and the importance of its early identification and management to reduce cardiovascular mortality.

The role of icodextrin in peritoneal dialysis: protocol for a systematic review and meta-analysis.

BACKGROUND: Previous meta-analyses have found several advantages of icodextrin compared with glucose in the application of peritoneal dialysis (PD), such as an improvement of peritoneal ultrafiltration during the long dwell and a reduction in episodes of uncontrolled fluid overload. However, the effect of icodextrin on patient-relevant outcomes remains unclear. This review aims to evaluate the benefits and harms of icodextrin in comparison with conventional glucose PD solution in patients with end-stage kidney disease receiving PD. METHODS: Randomized controlled trials of icodextrin comparing with conventional glucose solution in patients with end-stage kidney disease who received PD will be deemed eligible. We will conduct systematic searches in MEDLINE, EMBASE, CENTRAL, Ichushi-Web, Chinese and Japanese databases, and in clinical trials registries (ClinicalTrials.gov, International Clinical Trials Registry Platform Search Portal (ICTRP), EU Clinical Trials Register, Japan Registries Network (JPRN), China's Clinical Trial Registry (ChiCTR)). Furthermore, we will check conference proceedings and search references from relevant studies manually. Relevant pharmaceutical companies, authors, and experts will be contacted in an effort to identify further studies. We will not apply any limitations regarding language, publication status, and publication date when searching for eligible studies. The selection of studies, data extraction, and risk of bias assessment will be carried out by two independent reviewers. Data synthesis will be performed using RevMan 5 software with either a fixed effects model or random-effects model, depending on the presence of heterogeneity. For the assessment of statistical heterogeneity, I2 will be calculated. Sources of clinical heterogeneity will be evaluated through subgroup analyses. If there are ten or more studies included in the meta-analysis, we will investigate the publication bias using funnel plots and Egger's test. The quality of the body of evidence will be assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system. DISCUSSION: We assume that our systematic review will be more comprehensive compared to those published previously due to contacting the relevant pharmaceutical companies and a systematic search of published and unpublished non-English studies from China, Taiwan, and Japan. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42018096951.

The Association of Functional Status with Mortality and Dialysis Modality Change: Results from the Peritoneal Dialysis Outcomes and Practice Patterns Study (PDOPPS).

BACKGROUND: Little is known about the prevalence of functional impairment in peritoneal dialysis (PD) patients, its variation by country, and its association with mortality or transfer to hemodialysis. METHODS: A prospective cohort study was conducted in PD patients from 7 countries in the Peritoneal Dialysis Outcomes and Practice Patterns Study (PDOPPS) (2014 - 2017). Functional status (FS) was assessed by combining self-reports of 8 instrumental and 5 basic activities of daily living, using the Lawton-Brody and the Katz questionnaires. Summary FS scores, ranging from 1.25 (most dependent) to 13 (independent), were based on the patient's ability to perform each activity with or without assistance. Logistic regression was used to estimate the odds ratio (OR; 95% confidence interval [CI]) of a FS score < 11 comparing each country with the United States (US). Cox regression was used to estimate the hazard ratio (HR; 95% CI) for the effect of a low FS score on mortality and transfer to hemodialysis, adjusting for case mix. RESULTS: Of 2,593 patients with complete data on FS, 48% were fully independent (FS = 13), 32% had a FS score 11 to < 13, 14% had a FS score 8 to < 11, and 6% had a FS score < 8. Relative to the US, low FS scores (< 11; more dependent) were more frequent in Thailand (OR = 10.48, 5.90 - 18.60) and the United Kingdom (UK) (OR = 3.29, 1.77 - 6.08), but similar in other PDOPPS countries. The FS score was inversely and monotonically associated with mortality but not with transfer to hemodialysis; the HR, comparing a FS score < 8 vs 13, was 4.01 (2.44 - 6.61) for mortality and 0.91 (0.58 - 1.43) for transfer to hemodialysis. CONCLUSION: Regional differences in FS scores observed across PDOPPS countries may have been partly due to differences in regional patient selection for PD. Functional impairment was associated with mortality but not with permanent transfer to hemodialysis.

Single Daily Icodextrin Exchange as Initial and Solitary Therapy.

BACKGROUND: Incremental dialysis utilizes gradually increasing dialysis doses in response to declines in residual kidney function, and it is the preferred renal replacement therapy for patients who have just transitioned to end-stage renal disease (ESRD). Incremental peritoneal dialysis (PD) may impose fewer restrictions on patients' lifestyle, help attenuate lifetime peritoneal and systemic exposure to glucose and its degradation products, and minimize connections that could compromise the sterile fluid path. In this study, we utilized a 3-pore kinetic model to assess fluid and solute removal during single daily icodextrin treatments for patients with varying glomerular filtration rates (GFR). METHODS: Single icodextrin exchanges of 8 to 16 hours using 2- and 2.5-L bag volumes were simulated for different patient transport types (i.e., high to low) to predict daily peritoneal ultrafiltration (UF), daily peritoneal sodium removal, and weekly total (peritoneal + residual kidney) Kt/V (Kt/VTotal) for patients with residual renal GFRs ranging from 0 to 15 mL/min/1.73 m2. RESULTS: Daily peritoneal UF varied from 359 to 607 mL, and daily peritoneal Na removal varied from 52 to 87 mEq depending on length of icodextrin exchange and bag volume. Both were effectively independent of patient transport type. All but very large patients (total body water [TBW] > 60 L) were predicted to achieve adequate dialysis (Kt/VTotal ≥ 1.7) with a GFR of 10 mL/min/1.73 m2, and small patients (TBW: 30 L) were predicted to achieve adequate dialysis with a GFR of 6 mL/min/1.73 m2. CONCLUSIONS: A single daily icodextrin exchange can be tailored to augment urea, UF, and Na removal in patients with sufficient residual kidney function (RKF). A solitary icodextrin exchange may therefore be reasonable initial therapy for some incident ESRD patients.

Remote Patient Management in Automated Peritoneal Dialysis: A Promising New Tool.

Remote patient management (RPM) has the potential to help clinicians detect early issues, allowing intervention prior to development of more significant problems. A 23-year-old end-stage kidney disease patient required urgent start of renal replacement therapy. A newly available automated peritoneal dialysis (APD) RPM system with cloud-based connectivity was implemented in her care. Pre-defined RPM threshold parameters were set to identify clinically relevant issues. Red flag dashboard alerts heralded prolonged drain times leading to clinical evaluation with subsequent diagnosis of and surgical repositioning for catheter displacement, although it took several days for newly-RPM-exposed staff to recognize this issue. Post-PD catheter repositioning, drain times were again normal as indicated by disappearance of flag alerts and unremarkable cycle volume profiles. Identification of < 90% adherence to prescribed PD therapy was then documented with the RPM system, alerting the clinical staff to address this important issue given its association with significant negative clinical outcomes. Healthcare providers face a "learning curve" to effect optimal utilization of the RPM tool. Larger scale observational studies will determine the impact of RPM on APD technique survival and resource utilization.